None listed
Conditions
Brief summary
Intermittent has been shown to be beneficial in several medical conditions. Alzheimer's dementia has no definitive treatments yet. This study investigates the feasibility of intermittent fasting through time-restricted eating in people at risk for Alzheimer's dementia. The study hypothesis is that the feasibility of time-restricted eating in people at risk of Alzheimer's dementia will be comparable to normal diet.
Interventions
The intervention is intermittent fasting through time-restricted eating (TRE). It is defined as a longer than usual intervals between caloric meals. For this study 15 hours fasting five days a week will be investigated. During fasting participants will not consume any food that contains calory. Non-caloric items, such as water, black coffee or tea without sugar, and sparkling water are allowed.
A dementia specialist doctor will educate participants about the intervention. The education session
The intervention is intermittent fasting through time-restricted eating (TRE). It is defined as a longer than usual intervals between caloric meals. For this study 15 hours fasting five days a week will be investigated. During fasting participants will not consume any food that contains calory. Non-caloric items, such as water, black coffee or tea without sugar, and sparkling water are allowed. A dementia specialist doctor will educate participants about the intervention. The education session will involve one hour face to face session focusing on the health benefits and practical aspects of intermittent fasting. For example, the education session will inform participants that hunger pains are normal physiological reactions to empty stomach and they can be addressed by consuming a glass of water. The education will also cover common side effects of fasting such as, tiredness, irritability, and loss of lean body mass. The Occupational Therapist will provide the fasting diary and education about how to report fasting and exercise hours. The study team will consult participants' general practitioners to determine eligibility for participation. An occupational therapist who is a member of the study team will provide instructions about how to practise fasting. Adherence to the intervention will be monitored by a self-reported structured diary which has entry for each day. The total duration of the intervention is six months.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 60 years and 80 years (both inclusive). 2. A family history of dementia in an immediate biological family member. 3. Provide a signed and dated informed consent form to participate in the study.
Exclusion criteria
1. Presence of dementia and Mild Cognitive Impairment as defined by a score of 31 or less on the Modified Telephone Interview for Cognitive Status (TICS-M) during initial screening or a score less than 26 on the MoCA during in-person assessment. 2. Current major depressive disorder. 3. Existing diagnoses of any neurodegenerative diseases, strokes, and epilepsy. 4. Treatment with insulin or hypoglycemic drugs. 5. Contraindications for regular aerobic exercise (osteoarthritis, cardiac failure, coronary artery disease, serious cardiac arrythmia, such as a history of ventricular tachycardia). 6. Body mass index (BMI) is less than 23. 7. Frailty-Clinical Frailty Scale, category 4-9. 8. Medium and high risk falls as per Falls Risk Assessment Tool (FRAT). 9. Any medical condition that a participant’s general practitioner or the study doctor decides as unfit for time-restricted eating.
Outcome results
None listed